Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625469

Enrollment

Registered

2008-02-28

Start date

2007-10-31

Completion date

2009-12-31

Last updated

2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension, idiopathic pulmonary fibrosis, bosentan

Brief summary

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Detailed description

The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Interventions

DRUGbosentan

62.5mg orally bid for first month, followed by 125mg bid thereafter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Idiopathic Pulmonary Fibrosis referred for lung transplantation * Minimum 50 meter 6 minute walk distance * No significant underlying liver disease

Exclusion criteria

* Significant liver disease or cirrhosis * non ambulatory * previous adverse reaction/allergy to Bosentan

Design outcomes

Primary

Measure	Time frame	Description
6 minute walk distance	monthly assessement until date of lung transplantation	ATS Guideline 6MW distance before and after intervention

Secondary

Measure	Time frame	Description
right heart catheterization hemodynamics	variable based on time between listing and actual lung transplantation	pulmonary hemodynamics
chemokine peripheral blood analysis	monthly	battery of chemokines analyzed from the peripheral blood

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026